Wed.Jan 01, 2025

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CDSCO brings clinical trial site addition and change of PI applications to online mode

AuroBlog - Aurous Healthcare Clinical Trials blog

The Central Drugs Standard Control Organisation (CDSCO) has sought the industry to start submitting the applications for clinical trial site addition and change of principal investigator through online mode, as part of streamlining the regulatory submission procedure.

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Researchers Seek Women Who are Taking Zoloft® (sertraline) for Depression and/or Anxiety

Trialfacts

Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About the Research Center Research Center: UVA Health with Myriad Genetics Location: This is a study recruiting in Virginia and Maryland Lead Researcher: Dr. Jennifer L. Payne IRB: This study has been reviewed and approved by the University of Virginia Institutional Review Board HSR230396 About the Study How does pregnancy affect the way antidepressants work?

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Top Data and Technology Pieces of 2024

Pharmaceutical Commerce

This bucket of Pharma Commerce coverage is highly powered by digital solutions.

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Which Infectious Disease Could Be The Biggest Problem in 2025? An Expert Explains.

AuroBlog - Aurous Healthcare Clinical Trials blog

(Sean Anthony Eddy/Getty Images) COVID emerged suddenly, spread rapidly and killed millions of people around the world. Since then, I think it’s fair to say that most people have been nervous about the emergence of the next big infectious disease be that a virus, bacterium, fungus or parasite.

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Bridging Innovation & Patient Care: The Growing Role of AI

Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.

AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!

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Saving the Skinny Label Through the Skinny Label, Big Savings Act

FDA Law Blog

By Sara W. Koblitz Since the induced infringement finding in GSK v. Teva , the generic industry has feared the death of the skinny label (admittedly stoked by alarmist headlines like my own, see Ding Dong is the Skinny Label (Effectively) Dead? ). This is because, at a minimum, if a skinny-labeled generic is the basis for induced infringement liability, generic manufacturers will certainly think twice about using the skinny label process and still calling themselves AB-rated, which ultimately w

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India plays a significant role in global MedTech sector especially in emerging markets: Arpit Paliwal

AuroBlog - Aurous Healthcare Clinical Trials blog

India is playing an increasingly significant role in the global MedTech sector. As the demand for medical technologies rises, especially in emerging markets, India is well-positioned to meet these needs through its vast manufacturing capacity and innovative solutions, said Arpit Paliwal, director, HRS Navigation.

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